ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire
FDA device recall Z-0089-04 · posted 2003-11-06 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- Complaints were reported of difficulty in stent deployment.
- Action taken
- Sales representatives were sent notices via email on April 21, 2002. They were responsible for visiting each of their accounts, inform them of the Market Withdrawal and to return the device for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 155 units
- Distribution
- The device was distributed nationwide, Ireland and Jordan.
- Date initiated
- 2002-08-21
- Date posted
- 2003-11-06
- Date terminated
- 2003-12-11
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK ZILVER BILIARY STENT (K020788) | Wilson-Cook Medical, Inc. | 2002-05-08 |